Emergency Contraception Actual Use Study

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a non-comparative case series study to assess the ability of females 11-16 years of age, inclusive, who are requesting emergency contraception (EC) to use the study product, DR-104 (Plan B® 1.5), appropriately and safely without provider counseling.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duramed Research
• Treatments: Levonorgestrel

Criteria

Inclusion Criteria:

• Female and 11-16 years of age, inclusive

• Subject must be requesting emergency contraception for her own use (not for use by another person) and for current (not future) use

• Subject can read and understand English, according to her own judgment

• Others as dictated by FDA-approved protocol